Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)



Status:Recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:16 - 70
Updated:3/28/2019
Start Date:December 19, 2017
End Date:February 19, 2021
Contact:Novartis Pharmaceuticals
Email:Novartis.Email@novartis.com
Phone:1-888-669-6682

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A Phase 2, Multicenter, Open-Label Study to Assess PK/PD of SEG101 (Crizanlizumab), With or Without Hydroxyurea/Hydroxycarbamide, in Sickle Cell Patients With Vaso-Occlusive Crisis

The purpose of the CSEG101A2202 study is to characterize the PK and PD of
SEG101/crizanlizumab at 5 mg/kg and to evaluate the safety and efficacy of
SEG101/crizanlizumab in SCD patients.

Study CSEG101A2202 is designed as a Phase II, multicenter, open-label study. The first 45
patients (to identify 27 evaluable patients) will be enrolled to the treatment group
crizanlizumab 5.0 mg/kg to complete full PK/PD sampling at week 1 and week 15. In all
patients, trough PK/PD samples will also be collected prior to each dose. In addition,
throughout the study (and when possible), all patients will have blood drawn for serum to
assess PK and PD drawn at times of onset and resolution of each VOC event, fever, or
infection. Once the up to 45 patients are enrolled, 10 additional patients will be enrolled
to the exploratory treatment group and begin at 7.5 mg/kg of crizanlizumab.


Inclusion Criteria:

- Male and non-pregnant female patients 16-70 years of age (inclusive)

- Confirmed diagnosis of sickle cell disease by hemoglobin electrophoresis or
high-performance liquid chromatography (HPLC) [performed locally]. All sickle cell
disease genotypes are eligible.

- Experienced at least 1 VOC within the preceding 12 months prior to Screening, as
determined by medical history.

- If receiving HU/HC or erythropoietin stimulating agent, must have been receiving the
drug for at least 6 months prior to Screening

- Hemoglobin ≥4.0 g/dL. Absolute neutrophil count ≥1.0 x 109/L and platelet count ≥75 x
109/L

- Adequate renal and hepatic function as defined:

- GFR ≥45 mL/min/1.73 m2 calculated by CKD-EPI

- ALT ≤3 x ULN

- Direct (conjugated) bilirubin ≤2 x ULN

- ECOG performance status ≤2

- Written informed consent (or assent/ parental consent for minor subjects) prior to any
screening procedures

Exclusion Criteria:

- History of stem cell transplant.

- Acute VOC ending 7 days prior to first dosing

- Ongoing hospitalization prior to Screening

- Received blood products within 30 days to first dosing

- Participating in a chronic transfusion program (pre-planned series of transfusions for
prophylactic purposes)

- History of severe hypersensitivity reactions to other monoclonal antibodies

- Received a monoclonal antibody or immunoglobulin -based agent within 1 year of
Screening, or has documented immunogenicity to a prior biologic.

- Received active treatment on another investigational trial within 30 days (or 5
half-lives of that agent, whichever is greater) prior to Screening

- Significant active infection or immune deficiency (including chronic use of
immunosuppressive drugs)

- Resting QTcF ≥470 msec at pretreatment (baseline) or other cardiac or cardiac
repolarization abnormality

Other protocol-defined Inclusion/Exclusion criteria may apply.
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Greenville, North Carolina 27858
Principal Investigator: Darla K. Liles
Phone: +1 252 744 0456
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1 Tampa General Cir
Tampa, Florida 33606
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Phone: (813) 541-0254
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1405 Clifton Road NE
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Augusta, Georgia 30912
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
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Phone: 420-438-8199
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Bronx, New York 10467
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Charleston, South Carolina 29425
Principal Investigator: Julie Kanter-Washko
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Cherry Hill, New Jersey 08003
Principal Investigator: Ralph V Boccia
Phone: 301-571-2016
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Columbia, South Carolina 29203
Principal Investigator: M. Francisco Gonzalez
Phone: 803-840-8890
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Durham, North Carolina 27710
Principal Investigator: Nirmish Shah
Phone: 919-668-5178
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Miami, Florida 33136
Principal Investigator: Ofelia Alvarez
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New Brunswick, New Jersey 08903
Principal Investigator: Amanda Kaveney
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433 Southwest 10th Street
Ocala, Florida 34471
Principal Investigator: Rama Balaraman
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2776 Enterprise Rd # 100
Orange City, Florida 32763
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Philadelphia, Pennsylvania 19104
Principal Investigator: Kim Smith Whitley
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1583 Health Care Drive
Rock Hill, South Carolina 29732
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